MASH/MASLD Imaging
Medpace is a Leading Core Lab for MASH/MASLD Imaging
Medpace is a Leading Core Lab for MASH/MASLD Imaging
Global MASH Clinical Trial Imaging Operations
Medpace’s integrated core lab services enable our MASH/MASLD imaging experts to support your global development program through:
- Advanced quantitative imaging biomarkers for metabolic dysfunction-associated steatohepatitis (MASH) (formerly known as non-alcoholic steatohepatitis (NASH))
- Volumetric measurements for liver and spleen
- Fat content using MRI and/or MRS proton density fat fraction estimates (MRI-PDFF)
- Fibrosis/stiffness using MR elastography and/or FibroScan® acoustic elastography
- Full-service multi-platform imaging core lab (GCP & CFR-Part 11)
- Global site management
- Deep & broad MASH imaging experience
- Global reach with trials at more than 200 sites and more than 1000 patients
- Multi-site management and QA for trials with MRE, MRS, MRI, and FibroScan® biomarkers for MASH
Why Sponsors Partner with Medpace Core Labs for MASH Imaging
Through advanced imaging modalities, consistent image acquisition, streamlined processes, and integrated technology, Medpace enables seamless integration of imaging into clinical trial execution, ultimately accelerating the development of innovative MASH therapies.
Maximized Consistency of Image Acquisition Within and Across Sites
- Defined and verified scanners, acquisition parameters, anatomical coverage, and scanning protocols
- Established procedures for site qualification, routine quality assurance, and quality control
- Enrollment, image upload, and verification performed within a 21CFR part 11 compliant environment that maintains a full audit trail
Consistency of Image Review and Analysis
- Experienced project managers provide management and oversight
- Credentialed MRI technologists verify all image uploads for adequate image quality
- Qualified, board-certified centralized image readers/reviewers
ClinTrak® – Medpace Clinical Trial Management System
A powerful, proprietary image management software program purpose-built for supporting clinical trials
- Full integration of CTMS with imaging workflow (industry leader)
- Team of dedicated in-house developers
- Secure electronic transfer images/files
- 21 CFR Part 11 compliant
- 24/7 site support in various languages
- Image/scan tracking and archiving
- De-identification/masking
- Customized imaging eCRF
- Data management/query resolution and tracking
- Integrated image virtualized workstation
- Real-time web-based status reporting
